This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.

An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

Further study details as provided by Biosyn:

Primary Outcome Measures:

1. Number and size of bare spots, before and after simulated coitus.

2. Number of women with migration of gel into the endocervical canal and/or endometrial canal before and after simulated coitus.

Estimated Enrollment:

6

Detailed Description:

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.

Eligibility

Ages Eligible for Study:

18 Years to 45 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18 to 45 year old women

not pregnant

willingness to use effective method of contraception

regular menstrual cycle

normal Pap test result

Exclusion Criteria:

abnormal pelvic exam

pregnant or breastfeeding

claustrophobia or other MRI contraindications

hypertension, hemolytic anemia,latex allergy

history of hemorrhoids or irritable bowel syndrome

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260767